FOCUS 3 - A Study to Determine the Feasibility of Molecular Selection of Therapy Using KRAS, BRAF and Topo-1 in Patients With Metastatic or Locally Advanced Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3,240
- 试验地点
- 6
- 主要终点
- Topoisomerase-1 (topo-1) and K-ras, BRAF results obtained within 10 working days after registration
研究概览
简要总结
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors select the best treatment for patients and predict their response to treatment.
PURPOSE: This randomized phase II/III trial is studying how well tumor tissue testing works in selecting treatment for patients with metastatic or locally advanced colorectal cancer.
详细描述
OBJECTIVES:
Primary - Feasibility Study
- To determine the proportion of consenting patients that can provide a formalin-fixed paraffin-embedded block containing tumor.
- To determine the feasibility of topoisomerase-1 (topo-1) IHC and K-ras, BRAF mutational status determination being completed with 10 working days of initial consent.
- To determine reproducibility of results between reference laboratories.
- To determine the real costs of molecular testing.
- To determine the patients' ability to comprehend the study and their attitude during the waiting period for testing.
- To assess patients' ability to fully comprehend the trial as explained to them.
Secondary - Feasibility Study
- To further identify the EGFR-responsive subset within the K-ras wildtype population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Topoisomerase-1 (topo-1) and K-ras, BRAF results obtained within 10 working days after registration
Number of patients in which the interval between registration and randomization (RZ) is ≤ 10 days
Efficacy of fluorouracil with vs without irinotecan hydrochloride, fluorouracil, and leucovorin calcium (IrMdG) in low topo-1 tumors
Progression-free survival of patients with high topo-1 tumors treated with IrMdG with or without oxaliplatin
Efficacy of IrMdG with vs without cetuximab in K-ras wildtype tumors
Efficacy of IrMdG with vs without bevacizumab in K-ras mutant tumors
次要结局
- Time from release of tumor block to receipt by pathology lab
- If applicable, reason that RZ did not occur
- Time from registration to treatment start
- Time from data presentation to investigator to date of RZ
- Reproducibility of K-ras, BRAF, and topo-1 results
- Distribution frequencies
- Costs of molecular testing
- Toxicity according to NCI CTCAE v.3
- Response rates
- Progression-free survival
- Attitudes of patients about tests and treatment